United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

pharmacosmos uk ltd - ferric derisomaltose - solution for injection - 100mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

pharmacosmos uk ltd - ferric derisomaltose - solution for injection - 100mg/1ml

Israel - English - Ministry of Health

sanofi israel ltd - iron as iron iii sodium ferric glugonate compl. - solution for injection/ concentrate for solution for infusion - iron as iron iii sodium ferric glugonate compl. 62.5 mg / 5 ml - various combinations - various combinations - ferrlecit is indicated in adults and children 6 years and above.severe iron deficiency states only when oral administration has been found impossible; in cases of gastrointestinal malabsorption which rules out oral iron therapy; patients treated by dialysis getting erythropoietin.

United States - English - NLM (National Library of Medicine)

akebia therapeutics, inc. - tetraferric tricitrate decahydrate (unii: q91187k011) (ferric cation - unii:91o4lml611) - ferric cation 210 mg - auryxia is indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. auryxia is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis. auryxia is contraindicated in patients with iron overload syndromes (e.g., hemochromatosis) [see warnings and precautions (5.1)] . risk summary there are no available data on auryxia use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. animal reproduction studies have not been conducted using auryxia. skeletal and encephalic malformation was observed in neonatal mice when ferric gluconate was administered intraperitoneally to gravid dams on gestation days 7-9. however, oral administration of other ferric or ferrous compounds to gravid cd1-mice and wistar-rats caused no fetal malformation. an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. clinical considerations the effect of auryxia on the absorption of vitamins and other nutrients has not been studied in pregnant women. requirements for vitamins and other nutrients are increased in pregnancy. risk summary there are no human data regarding the effect of auryxia in human milk, the effects on the breastfed child, or the effects on milk production. data from rat studies have shown the transfer of iron into milk by divalent metal transporter-1 (dmt-1) and ferroportin-1 (fpn-1). hence, there is a possibility of infant exposure when auryxia is administered to a nursing woman. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for auryxia and any potential adverse effects on the breastfed child from auryxia or from the underlying maternal condition. the safety and efficacy of auryxia have not been established in pediatric patients. juvenile animal toxicity data in animal studies, greater gastrointestinal toxicity was observed when ferric citrate was administered by gavage as compared to administration with solid food. because auryxia is recommended to be taken with meals and patients under 6 months of age are unlikely to be eating solid food, they may be at greater risk of gastrointestinal toxicity. clinical studies of auryxia included 292 subjects aged 65 years and older (104 subjects aged 75 years and older). overall, the clinical study experience has not identified any obvious differences in responses between the elderly and younger patients in the tolerability or efficacy of auryxia.

United States - English - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - sodium ferric gluconate complex (unii: cc9149u2qx) (ferric cation - unii:91o4lml611) - ferric cation 12.5 mg in 1 ml - ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. ferrlecit is contraindicated in patients with known hypersensitivity to sodium ferric gluconate or any of its components. reactions have included anaphylaxis [see warnings and precautions (5.1)] . risk summary parenteral iron administration may be associated with hypersensitivity reactions [see warnings and precautions (5.1)] , which may have serious consequences, such as fetal bradycardia (see clinical considerations) . advise pregnant women of the potential risk to the fetus. available data from postmarketing reports with ferrlecit use in pregnancy are insufficient to assess the risk of major birth defects and miscarriage. ferrlecit contains benzyl alcohol as a preservative. because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

baxter healthcare (malaysia) sdn. bhd. - iron (iii)- hydroxide sucrose complex -

Australia - English - Department of Health (Therapeutic Goods Administration)

bnutrition pty ltd - levomefolate glucosamine, quantity: 27 microgram/ml (equivalent: levomefolic acid, qty 15 microgram/ml); mecobalamin, quantity: 0.09 microgram/ml; pyridoxal 5-phosphate monohydrate, quantity: 88 microgram/ml (equivalent: pyridoxine, qty 50 microgram/ml); ferric pyrophosphate, quantity: 3.325 mg/ml (equivalent: iron, qty 1 mg/ml) - oral liquid - excipient ingredients: purified water; xanthan gum; glycerol; potassium sorbate; dextrin; sodium chloride; lecithin; flavour - maintain/support energy levels ; maintain/support heat/energy production/thermogenesis ; maintain/support healthy growth and development ; maintain/support general health and wellbeing ; aid/assist healthy red blood cell production ; maintain/support blood health ; helps maintain/support transport of oxygen in the body ; aid/assist/helps oxygen transport to body tissues ; helps maintain/support haemoglobin formation/synthesis ; maintain/support immune system health ; maintain/support healthy immune system function ; aid/assist/helps protein synthesis in the body ; helps prevent dietary (state vitamin/mineral/nutrient) deficiency ; aid/assist/helps metabolism of (state vitamin/mineral/nutrient) ; maintain/support cognitive development ; aid/assist/helps synthesis of neurotransmitters ; maintain/support nervous system health ; maintain/support nervous system function

Australia - English - Department of Health (Therapeutic Goods Administration)

bnutrition pty ltd - biotin, quantity: 1.6 microgram/ml; mecobalamin, quantity: 0.18 microgram/ml; calcium ascorbate dihydrate, quantity: 3.41 mg/ml (equivalent: ascorbic acid, qty 2.8 mg/ml; equivalent: calcium, qty 320 microgram/ml); riboflavin sodium phosphate, quantity: 80 microgram/ml (equivalent: riboflavin, qty 60 microgram/ml); zinc glycinate, quantity: 4 mg/ml (equivalent: zinc, qty 1.2 mg/ml); nicotinamide, quantity: 400 microgram/ml; manganese amino acid chelate, quantity: 1 mg/ml (equivalent: manganese, qty 200 microgram/ml); levomefolate glucosamine, quantity: 72.13 microgram/ml (equivalent: levomefolic acid, qty 40 microgram/ml); pyridoxal 5-phosphate monohydrate, quantity: 176 microgram/ml (equivalent: pyridoxine, qty 100 microgram/ml); d-alpha-tocopheryl acetate, quantity: 2 mg/ml; dibasic magnesium phosphate trihydrate, quantity: 24 mg/ml (equivalent: magnesium, qty 3.3 mg/ml); thiamine hydrochloride, quantity: 89 microgram/ml (equivalent: thiamine, qty 80 microgram/ml); potassium iodide, quantity: 11.8 microgram/ml (equivalent: iodine, qty 9 microgram/ml); choline bitartrate, quantity: 20 mg/ml (equivalent: choline, qty 8.26 mg/ml); betacarotene, quantity: 1 mg/ml; calcium phosphate, quantity: 26.4325 mg/ml (equivalent: calcium, qty 10.0007 mg/ml); ferric pyrophosphate, quantity: 3.325 mg/ml (equivalent: iron, qty 1 mg/ml); colecalciferol, quantity: 0.5 microgram/ml - oral liquid - excipient ingredients: citric acid; xanthan gum; potassium sorbate; glycerol; purified water; maize starch; ascorbyl palmitate; gelatin; maize oil; dl-alpha-tocopherol; sucrose; lecithin; flavour; dextrin; sodium chloride; vegetable oil - antioxidant/reduce free radicals formed in the body ; helps reduce/decrease free radical damage to body cells ; maintain/support collagen formation ; maintain/support energy levels ; helps convert (state food) into energy ; maintain/support body metabolism/metabolic rate ; maintain/support energy production ; maintain/support heat/energy production/thermogenesis ; maintain/support healthy eye function ; maintain/support eye health ; maintain/support healthy eyesight/vision ; maintain/support healthy growth and development ; maintain/support general health and wellbeing ; aids/assists teeth development ; maintain/support healthy teeth ; maintain/support teeth mineralisation ; maintain/support connective tissue health ; aid/assist/helps connective tissue production/formation ; maintain/support healthy body tissues ; maintain/support bone health ; aids/assists healthy bone development/growth/building ; maintain/support bone strength ; help maintain/support bone mineralisation ; aid/assist healthy red blood cell production ; maintain/support red blood cell health ; maintain/support blood health ; helps maintain/support transport of oxygen in the body ; aid/assist/helps oxygen transport to body tissues ; helps maintain/support haemoglobin formation/synthesis ; maintain/support immune system health ; maintain/support healthy immune system function ; maintain/support muscle function ; maintain/support healthy neuromuscular system/function ; aid/assist/helps glucose/sugar/carbohydrate metabolism ; aid/assist/helps protein synthesis in the body ; maintain/support absorption of dietary (state vitamin/mineral/nutrient) ; maintain/support (state vitamin/mineral/nutrient) levels in the body ; helps prevent dietary (state vitamin/mineral/nutrient) deficiency ; aid/assist/helps metabolism of (state vitamin/mineral/nutrient) ; maintain/support cognitive development ; maintain/support cognitive function/mental function ; maintain/support nerve conduction ; aid/assist/helps synthesis of neurotransmitters ; maintain/support nervous system health ; maintain/support nervous system function ; maintain/support skin health ; maintain/support skin integrity/structure ; maintain/support skin regeneration ; maintain/support wound healing

New Zealand - English - Medsafe (Medicines Safety Authority)

a. menarini new zealand pty ltd - ferric derisomaltose 417 mg/ml equivalent to 100 mg/ml elemental iron - solution for injection - 100 mg/ml - active: ferric derisomaltose 417 mg/ml equivalent to 100 mg/ml elemental iron excipient: hydrochloric acid sodium hydroxide water for injection - monofer is indicated for the treatment of iron deficiency in adults, under the following conditions: · when oral iron preparations are ineffective or cannot be used. · where there is a clinical need to deliver iron rapidly the diagnosis must be based on laboratory tests

New Zealand - English - Medsafe (Medicines Safety Authority)

a. menarini new zealand pty ltd - ferric derisomaltose 417 mg/ml equivalent to 100 mg/ml elemental iron - solution for injection - 1000 mg/10ml - active: ferric derisomaltose 417 mg/ml equivalent to 100 mg/ml elemental iron excipient: hydrochloric acid sodium hydroxide water for injection - monofer is indicated for the treatment of iron deficiency in adults, under the following conditions: · when oral iron preparations are ineffective or cannot be used. · where there is a clinical need to deliver iron rapidly the diagnosis must be based on laboratory tests